The Recall Desk
HighFDA (Devices)·Z-0415-2016·Announced 2015-12-23

MOOG Medical Devices Recalls EnteraLite Infinity Enteral Pump Delivery Sets

MOOG Medical Devices Group is recalling EnteraLite Infinity Enteral Pump Delivery Sets because the purple ENFit connector may crack or break, causing leaks.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk of harm (leaking of enteral nutrients) where specific injury reports are not detailed in the source text, fitting the 'High' severity criteria for risk-of-harm products.

Plain-English summary

MOOG Medical Devices Group is recalling specific EnteraLite Infinity Enteral Pump Delivery Sets. The affected products include Catalog Nos. INF0020-A, INF0500-A, INF1200-A, and GR1200-A. These sets are used to dispense liquid nutrients at a preprogrammed pump or user-controlled rate.

The recall is due to a potential for leaking between the purple ENFit connector and the white transitional stepped connector. This issue may occur if the purple connector cracks or breaks. The agency has classified this as a Class II recall.

Approximately 12,014,130 sets were distributed to the state of Minnesota. Consumers and healthcare providers should stop using the affected sets and contact MOOG Medical Devices Group for instructions on replacement or return.

The recalled product

Product
Catalog No. INF0020-A  EnteraLite Infinity Enteral Pump Delivery Set with ENFit Connector System and Transitional Stepped Connector (spiked set); Catalog No. INF0500-A - 500ml EnteraLite Infinity Enteral Pump Delivery Set with ENFit Connector System and Transitional Stepped Conn
Affected units
12,014,130

Distribution

Distributed in 1 state:

Same manufacturer · MOOG Medical Devices Group

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